Code of ethics, Ethical principles, code of professional conduct, Ethics committee

Research
Code of ethics
Ethical principles
code of professional conduct
Ethics committee

1. CODE OF ETHICS AND ETHICS COMMITTEE DR.S.NIRANJANI ASSOCIATE PROFESSOR TAGORE COLLEGE OF NURSING Let's get started

2. Let's get started Back to Agenda Page

3. PURPOSE SESSION HIGHLIGHTS Definition of ethics Introduction ICN CODE OF ETHICS Ethical Principles INC Code of Ethics for Nurses in India ETHICS COMMITTEE

4. Introduction Within the given profession, a code of ethics serves as a means of self regulation and a source of guidelines for individual behaviour and responsibility. Professional code of ethics are a system rules and principles by which that profession is expected to regulate its members and demonstrate its responsibilities to the society. In India, Nurses are following the international council of Nurses code for nurses 1993. ICN Back to Agenda Page

5. DEFINITION Back to Agenda Page Ethics are the principles of conduct governing one’s relationship with others, basic beliefs about right and wrong. The nursing code of ethics is a guide for “ carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession”.

6. PURPOSE Standards for the behaviours of the nurses and provide general guidelines for the nursing action. Helps to distinguish between the Right and the Wrong . Enables a correct decision . Protect the rights of the Individual . Back to Agenda Page

7. ICN CODE OF ETHICS Nurses and People . Nurses and Practice . Nurses and Society . Nurses and Co-workers . Nurses and the Profession.

8. 1 . Nurses and People The nurse’s primary responsibility is to that person who requires Nursing care . The nurse provides care, promotes an environment in which the values, costumes and the spiritual beliefs of the individual are respected. The nurse holds confidence, personal information and uses judgement in sharing their information. The nurse ensures that the individual receives sufficient information on which to base consent for care and related treatment. The nurse shares with the society the responsibility for initiating and supporting action to meet the health and social needs of the public

9. 2.Nurses and Practice The nurse carries personal responsibility for nursing practice , for maintaining competence by continuing learning. The nurse maintains a standard of personal health such that the ability to provide care is not compromised. The nurse uses judgement regarding individual competence when accepting and delegating responsibility. The nurse at all times maintains standards of personal conduct which reflect well on the profession and enhance public confidence. The nurse, in providing care ensures that use of technology and scientific advances are compatible with the safety, dignity and rights of the people.

10. 3.Nurse and Society The nurse shares with other citizens the responsibility for initiating and supporting actions to meet the health and social needs of the public. Recognize and perform the duties of citizenship . Aware of laws and regulations which affect the practice of medicine and nursing.

11. 4. Nurses and Co-workers The nurse sustains a cooperative relationship with co-workers in nursing and other fields. The nurse takes appropriate action to safeguard individuals, families and communities when their health is endangered by a co-worker or any other person.

12. 5. Nurses and the Profession The nurse plays the major role in determining and implementing desirable standards of nursing practice and nursing education. The nurse is active in developing a care of professional knowledge . The nurse acting through the professional organization, participates in establishing and maintaining equitable, social and economic working conditions in nursing . Back to Agenda Page

13. Ethical Principles “ The most fundamental universal principle is respect for the people ” The major Ethical principles are: It is called as Freedom of choice or accepting responsibility for one’s choice. So it requires that health personnel obtain a patient’s informed consent for treatment and for participation in research. AUTONOMY The beneficence principle states that the actions one take should be in an effort to promote the good. It requires the balancing of Harms and Benefits . BENEFICENCE Nonmaleficence The principle states that one should do no harm. The nurse should interpret the term “HARM” to mean emotional and social as well as physical injury.

14. It means “Obligation to tell the truth”. It requires professional caregiver to provide with accurate, reality based information about their health status to the patient’s. Veracity It concerns the issue that person should be treated equally and fairly. Justice Confidentiality It is the duty to respect privileged information. The principle of confidentiality provide that caregivers should respect the patient’s needs for privacy and use of personal information about him/her only to improve care. It is keeping one’s promises and commitment. The principle of fidelity holds that the person should faithfully fulfill his duties and obligations Fidelity Back to Agenda Page

15. INC Code of Ethics for Nurses in India A. The nurse respects the uniqueness of the individual in provision of care. Provides care for individuals without consideration of caste, creed, religion, culture, ethnicity, gender, socio-economic and political status, personal attributes or any other grounds. Providing care considering the beliefs, values and cultural sensitivities . Appreciates the place of the individual in family and community and facilitates participation of significant others in the care. Develops and promotes a trustful relationship with the individuals . Recognizes the uniqueness of response of the individuals to interventions and adapts accordingly.

16. INC Code of Ethics for Nurses in India B. The nurse respects the rights of individuals as partner in care and helps in making informed choices. Respects the decision made by the individual regarding their care. Protects public from misinformation and misinterpretations Advocates special provision to protect vulnerable individuals/groups .

17. INC Code of Ethics for Nurses in India C. The nurse respects individual’s right to privacy , maintains confidentiality and shares information judiciously. Respects the individuals right to privacy of their personal information . 2 . Maintains confidentiality of privileged information except in life threatening situation and uses discretion in sharing information.

18. INC Code of Ethics for Nurses in India D. The nurse maintains competence in order to render quality nursing care. 1. Nursing care must be provided only by a registered nurse . 2. Nurse strive to maintain quality nursing care and also upholds the standard of care. 3. Nurse values continuing education , initiates and utilizes all opportunities for self development. 4. Nurse values research as a means of development of nursing profession.

19. INC Code of Ethics for Nurses in India E. The nurse should practice within the framework of ethical, professional and legal boundaries. Follow/practice the code of ethics and code of professional conduct for nurses in India developed by Indian Nursing Council. 2 . Should be familiar with the relevant laws and practice in accordance with the laws of the state. F. Nurse is obliged to work harmoniously with the members of the health team. Appreciate the team efforts . 2 . Co-operates, co-ordinates and collaborates with the members of the health team to meet the needs of the people.

20. Professional Responsibility and Accountability Nursing Practice INC CODE OF PROFESSIONAL CONDUCT FOR NURSES IN INDIA Communication and Interpersonal Relationships Valuing Human Being Management & Professional Advancement

21. INC Code of Professional conduct for Nurses in India Professional Responsibility and Accountability : Appreciates sense of self worth and nurtures it. Carries out responsibilities within the framework of the professional boundaries. Is accountable for maintaining practice standards set by Indian Nursing Council. Is accountable for own decisions and actions . Is compassionate. Is responsible for continuous improvement of current practices. GO BACK TO HEADING

22. INC Code of Professional conduct for Nurses in India Nursing Practice : Provides care in accordance with set standards of practice. Treats all individuals and families with human dignity in providing physical, psychological, emotional, social and spiritual aspects of care. Respects individuals and families in the context of traditional and cultural practices. Ensures safe practice . Presents realistic picture truthfully in all situations for facilitating autonomous decision making by individuals and families . GO BACK TO HEADING

23. INC Code of Professional conduct for Nurses in India Communication and Interpersonal Relationships: Establishes and maintain effective interpersonal relationship with individuals, families and the communities. Upholds the dignity of team members and maintain effective interpersonal relationship with them. Appreciated and nurtures the professional role of team members . Co-operates with other health professionals to meet the needs of the individuals, families and the communities . GO BACK TO HEADING

24. INC Code of Professional conduct for Nurses in India Valuing Human Being: Takes appropriate action to protect individuals from harmful unethical practices. Encourages and support individuals in their right to speak for themselves on issues affecting their health and welfare. Respects and supports choices made by the individuals GO BACK TO HEADING

25. INC Code of Professional conduct for Nurses in India Management: Ensures appropriate allocation and utilization of the resources . Participates in supervision and education of students and other formal care providers. Facilitates conductive work culture in order to achieve institutional objectives. Communicates appropriately using channels of communications. Participates in performance appraisal and evaluation of nursing services. Works with individuals to identify their needs and funding agencies for resources allocation .

26. INC Code of Professional conduct for Nurses in India Professional Advancement : Ensures the protection of human rights while pursuing the advancement of knowledge. Contributes to the development. Participates in determining and implementing quality care . Takes responsibility for updating own knowledge . Contributes to the core of professional knowledge by conducting and participating in research . GO BACK TO HEADING

27. ETHICS COMMITTEE

28. INTRODUCTION An ethics committee is a committee formally designated to review and approve the initiation of a clinical research study involving human participants and to provide continuing review of the research study • Ethics committee is also known as IRB outside india • Any institution and organisation which intends to conduct Biomedical and health research required ethics committee according to National Ethical Guidelines.

29. COMPOSITION OF THE ETHICS COMMITTEE Heterogeneous group of at least 7 members (max. 15) • Oriented to the cause of ethics Proficient to review and evaluate Qualified by training (GCP)

30. COMPOSITION OF THE ETHICS COMMITTEE The composition may be as follows Chairperson Member secretary 1-2 basic medical scientists(preferably one pharmacologist) 1-2 clinicians from various institutes One legal expert or retired judge One social scientist/representative of non governmental voluntary agency One philosopher/ethicist/theologian • One lay person from the community

31. QUALIFICATIONS OF COMMITTEE MEMBERS Chairperson : Non-affiliated A well-respected person from any background with prior experience of having served/serving in an EC Member secretary : Affiliated Should be a staff member of the institution Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills S hould be able to devote adequate time to this activity which should be protected by the institution

32. QUALIFICATIONS OF COMMITTEE MEMBERS 1-2 basic medical scientists(preferably one pharmacologist) : Affiliated/ non-affiliated Non-medical or medical person with qualifications in basic medical sciences In case of EC reviewing clinical trials with drugs, the basic medical scientist should preferably be a pharmacologist 1-2 clinicians from various institutes : N on-affiliated Should be individual/s with recognized medical qualification, expertise and training

33. QUALIFICATIONS OF COMMITTEE MEMBERS One legal expert or retired judge : Affiliated/ non-affiliated Should have a basic degree in Law from a recognized university, with experience Training in medical law. One social scientist/representative of non governmental voluntary agency/philosopher/ethicist : Affiliated/ non-affiliated Should be an individual with social/ behavioural science/ philosophy/ religious qualification and training and/or expertise and be sensitive to local cultural and moral values . Can be from an NGO involved in health-related activities

34. QUALIFICATIONS OF COMMITTEE MEMBERS One lay person from the community: Non-affiliated Literate person from the public or community Has not pursued a medical science/ health related career in the last 5 years May be a representative of the community from which the participants are to be drawn Is aware of the local language, cultural and moral values of the community Desirable : involved in social and community welfare activities

35. REGISTRATION Every ethics committee constituted under rule 7,shall make an application for grant of registration to the central licencing authority in form CT-o1 The ethics committee shall furnish such information and documents as specified in the schedule along with the application made in form CT-01 The central licencing authority shall scrutinise the information and document under sub rule 2 Validity 5 years from the date of issue, unless suspended or cancelled by Central licencing authority Renewal should be done after expiry 90 days prior to date of expiry

36. ETHICS COMMITTEE ROLE & RESPONSIBILITY : BEFORE THE STUDY BEGINS: EC registration Having the SOPs (standards of procedures) in place Investigator eligibility , site feasibility, conflicts of interests Review of research proposal (within reasonable time) Decision making in formal meeting, documented Issuing an approval (in appropriate format) Record keeping (meeting agenda, meeting minutes, decisions communicated to investigator, annual/final study report)

37. ETHICS COMMITTEE ROLE & RESPONSIBILITY : During the study: Review of all EC notifications - amendments (protocol, ICD), protocol deviations Review of (Serious adverse effect) SAE reporting, analysis, relatedness assessment, deciding compensation Monitoring study progress and periodic review of study conduct Communicating with INV, RA, Subject (if needed) Allowing regulatory inspection Record keeping (meeting agenda, meeting minutes, decisions communicated to INV, annual/final report )

38. ETHICS COMMITTEE ROLE & RESPONSIBILITY : After the study: Review of SAE reporting, analysis, relatedness assessment, deciding compensation Communicating with INV, RA, Subject (if needed) Reviewing study report Post trial management Publishing Record keeping – archival Allowing regulatory inspection

39. ROLE & RESPONSIBILITY OF IEC MEMBERS : Regularly attend and actively participate in the EC meetings Review ,discuss and consider research proposals submitted for evaluation. Reviewers for each proposal will review the study. later, if any other issues the other IEC members can voice their comments/suggestions. Discuss serious adverse event reports and recommend appropriate action, review the progress reports and monitor ongoing studies as appropriate Evaluate final reports and outcomes Maintain confidentiality of the documents and deliberations of IEC meetings Declare any conflict of interest

40. ROLE & RESPONSIBILITY OF IEC MEMBERS : Participate in continuing education activities in biomedical ethics and biomedical research If deemed necessary should suggest any changes that may be necessary to be included in the SOPs of the IEC Conduct monitoring visits for any research proposal, if needed